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OpenTrials
Completed

NCT Number: NCT02362919

Influenza Vaccination Among the Elderly Individuals

The aims of the study are to a) identify individuals with a poor response to influenza vaccination and b) identify factors associated with a poor response to influenza vaccination.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

This is a population-based prospective cohort study. Potential participants, males and females between 65 and 80 years of age, were selected randomly through the resident registration office in Hannover city, Germany and invited with a personalized letter to participate in the study.

Initially, a blood sample (40 ml) will be drawn from each participant (day 0). Furthermore, participants will be vaccinated against influenza with FLUAD 2014/2015. FLUAD is a trivalent, surface antigen, inactivated influenza virus vaccine adjuvanted with MF59C.1. Additional five blood samples will be collected during the study period of four months (at days 3, 7, 21, 70 and 130). Information about current and past infections, chronic diseases and basic sociodemographic data will be collected through a self-administered questionnaire.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals between 65 and 80 years of age

Exclusion criteria

  • Individuals with a known hypersensitivity to any of the excipients and to eggs, chicken Protein, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide
  • Individuals, who have an acute infection during the visit at the study Center
  • Individuals with cognitive impairment
  • Individuals already vaccinated with influenza vaccination in the influenza season 2014/15

Treatment and study plan

Primary outcomes

  1. Serological evidence of vaccine response to influenza vaccination

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Helmholtz Centre for Infection Research

Other

Collaborators

  • Clinical Research Center, Hannover, Germany
  • Hannover Medical School
  • Hannover Unified Biobank, Hannover, Germany

Registry information

Official study title

Determinants of Vaccine Response to Influenza Vaccination Among Individuals Over 65 Years of Age - a Population-based Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2015
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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